Kornimate/medical-research-clean huggingface dataset:
asynchrony during mechanical ventilation in patients with acute respiratory distress syndrome

Conditions: Respiratory Distress Syndrome, Adult; Ventilator-Induced Lung Injury

Summary: asynchrony during mechanical ventilation has been poorly described in patients suffering from acute respiratory distress syndrome. the purpose of this study is to describe the frequency of asynchronies (ineffective efforts and double triggering) in these group and evaluate potential risk factors and prognosis implications.

major patient-ventilator asynchronies have been described during assisted mechanical ventilation in different settings. few studies have evaluated double cycling in ards patient. no clear predictors of this finding beside low tidal volume have been found, and clinical outcome implications have not been addressed. this study has 3 main objectives: evaluate the frequency of double cycling and ineffective efforts, seek for potential predictors and clinical outcomes related to asynchronies. subjects with less than 72 hours of mechanical ventilation due to ards will be recruited. thirty minutes of mechanical ventilation will be recorded and automatically analyzed with a custom-made program to detect asynchronies. a blood sample will be drawn to measure inflammatory and lung tissue damage biomarkers. clinical and outcome data will be recorded.

Eligibility criteria:
inclusion criteria: * acute respiratory distress syndrome according to berlin definition * intubation and mechanical ventilation within 72 hours of inclusion exclusion criteria: * known severe neuromuscular disease * continuous neuromuscular blocking agents infusion
role of parenting skills and parenting style in pediatric weight loss programs

Conditions: Pediatric Obesity

Summary: the purpose of this study is to evaluate the role of different parenting skills and parenting styles in the success of children enrolled in a family-based behavioral weight control program and to compare these skills and styles to those used by families with normal weight children.

pediatric overweight has nearly tripled in the past several decades and while family-based behavioral weight control programs are the mainstay of treatment, there is considerable variability in their outcomes. parents play an important role in the success of their children, particularly by implementing new behavioral skills. however recent evidence has also suggested that parenting style, or the way a parent interacts with their child and provides emotional support and discipline, may be another key element in pediatric weight control. our goal is to evaluate the role of specific parenting (behavioral) skills and parenting style in the success of children enrolled in a standard family-based behavioral weight control intervention. our goal is to examine whether specific parenting (behavioral) skills and parenting style change during the intervention and whether or not this change is related to changes in the child's bmi z-score.

Eligibility criteria:
inclusion criteria: * children between and including the ages of 8-12 years old * child bmi \>= 85th percentile * parent willing to attend all treatment meetings * parent and child must be able to speak, read, and understand english exclusion criteria: * a family member who is participating in another weight loss program * the child has any serious medical problem that would limit his/her participation in the study, for example, gastrointestinal diseases, cardiac disease, immune compromised state, chronic steroid use or other medication that impacts weight, developmental delays. * child with serious food allergies that would compromise adherence to dietary recommendations * any family member has a major psychiatric disease or organic brain syndrome * family is going to move outside the metropolitan area within the time frame of the study

Keywords: pediatric obesity parenting style feeding style behavioral skills parenting skills family meals
pegliposomal doxorubicin and 5-fluorouracil as second line therapy for metastatic gastric cancer

Conditions: Gastric Cancer

Summary: for second-line chemotherapy for metastatic gastric cancer, single-agent irinotecan is the standard treatment. anthracyclines are active but lack well designed investigations. the combination of epirubicin, fluorouracil and cisplatin (or oxaliplatin) are widely used in europe. however, traditional anthracyclines are more cardiotoxic; and (pegliposomal doxorubicin) pld, as a new liposome dosage form of doxorubicin, has better cardiac safety. therefore, we designed this phase ii trial with pld and 5-fu to compare irinotecan monotherapy in the second-line treatment.

patients with metastatic gastric cancer failed to first-line therapy will be radomized to arm a with pld and 5-fu and arm b with irinotecan single agent therapy. both regimens will be treated every 2 weeks until disease progression or untolerable toxicity. efficacy will be assessed every 3 cycles and safety will be evaluated every cycle.

Eligibility criteria:
inclusion criteria: 1. age 18-70 years old; 2. metastatic gastric cancer progressed on first-line treatment; 3. expected survival time ≥ 3 months; 4. at least one evaluable target lesion according to the solid tumor evaluation criteria (recist) version 1.1; 5. ecog ps 0\~2; 6. adequate bone marrow function reserve: white blood cell count ≥ 3.0 × 10\*9 / l, neutrophil count ≥ 1.5 × 10\*9/ l; platelet count ≥ 100 ×10\*9/ l; hemoglobin ≥ 90 g / l; 7. adequate liver and renal function reserve: ast and alt ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 2 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value; 8. lvef ≥ 55 %; 9. be able to understand the research process, volunteer to participate in the study, and sign an informed consent form. exclusion criteria: 1. patients known to be allergic to active or other components of chemotherapeutic drugs; 2. patients who have been treated with pld or irinotecan in the past; 3. according to the researcher's judgment, other anti-tumor treatments such as radiotherapy and surgical resection are required during chemotherapy; 4. those who are not expected to be able to tolerate chemotherapy with severe heart disease or discomfort; 5. d-mmr or msi-h or her-2 overexpression; 6. severe or uncontrolled infections or diabetes; 7. history of other malignacis in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin); 8. participated in other clinical trials within 4 weeks prior to the start of the study; 9. pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study.

Keywords: pegliposomal doxorubicin
the role of high-flow nasal cannula therapy in the treatment of acute carbon monoxide poisoning

Conditions: Carbon Monoxide Poisoning

Summary: the aim of the study is to test whether oxygen therapy delivered through high-flow nasal cannula devices in patients admitted to the emergency department for acute carbon monoxide poisoning is superior to the non-rebreathing oxygen face mask therapy with a 15 l/minute oxygen flow (currently the first-line therapy), in terms of reduction of carboxyhemoglobin (cohb) concentration and delayed neurological sequelae incidence.


Eligibility criteria:
inclusion criteria: * age v 18 years * carbon monoxide intoxication as major problem leading to emergency department admission * carboxyhemoglobin (cohb) concentration 10% at the time of enrolment exclusion criteria: * age \< 18 years * glasgow coma scale ≤ 13 * refusal to give consent
effect of the enriched environment on the risk of relapse

Conditions: Alcoholic Relapse

Summary: this clinical study investigates the effects of enriched environment on the risk of relapse in alcoholic patients. 135 patients hospitalized for an alcoholic addiction will be recruited and randomized in two groups: one group will receive standard of care, the other group will receive a treatment with enriched environment. the enriched environment consists of six sessions of virtual reality (20 minutes) in a multi-sensory pod and six sessions (20 minutes) of bike activity with cognitive tasks while pedalling. the multi-sensory virtual reality pod allows mindfulness practice and allows patients to be in immersive situations that may trigger cues in order to help them in craving management. the bike consists in the combination of a pedal set and a touch pad on which cognitive training games are offered. this tool thus makes it possible to simultaneously stimulate motor skills and cognition by means of bicycle-game coupling. patients are then followed during 3 months and a half.


Eligibility criteria:
inclusion criteria: * any patient hospitalized at the henri laborit hospital for alcohol addiction, on an opened unit for at least 48 hours; * woman or man aged between 18 and 65 inclusive * severe alcohol use disorder according to the 5th edition of the diagnostic and statistical manual of mental disorders * benefit from social security or benefit from it through a third party in accordance with french law on research involving the human person * have signed the informed consent form after receiving written information. exclusion criteria: * disabling cognitive disorders * cardiological pathologies that could compromise the participation of patients, detected by an ecg. * advanced pulmonary, renal, and hepatic diseases, or any unstable and serious medical conditions that could compromise the patient's participation in the study, subject to the judgment of the doctor * hypertension * ataxia * uncompensated and unstable psychiatric pathology * susceptibility to cybersickness * pregnant or breastfeeding woman * simultaneous participation in another trial * any other current addiction, except addiction to tobacco and benzodiazepines * employee of the investigator or of the clinical study site * patients protected by law * people not covered by state health insurance * patients who in the opinion of the investigator are unable to complete the questionnaires
treating depression in patients with de quervain's tenosynovitis; an integrated web based skills intervention

Conditions: De Quervain Disease

Summary: this study evaluates a decision aid to help patients with de quervain's tenosynovitis decide how to treat their condition. for patients with symptoms of depression, half the participants will receive a psychological intervention (toolkit) to improve depression and pain from de quervain's tenosynovitis. the investigators hypothesize that both the decision aid and the toolkit will be feasible, and that the toolkit will improve pain and function compared to usual care.

the investigators are doing this research to see if they can improve the management of patients with de quervain's tendinopathy. in the first part of this study, a decision aid (da) has been developed to help participants make choices about their treatment. decision aids are designed to provide patients with balanced, complete, and understandable information about their options for management of their condition, as well as risks and benefits, in order to help them determine their preferences according to their values. research has shown that patients felt more knowledgeable and better informed with a more active role in decision making after using das. additionally, research has shown that depression affects pain and disability experienced by patients with de quervain's tenosynovitis. in the second part of our study, the investigators want to see whether a web based skills intervention (toolkit) is more effective than usual medical care in improving pain and disability in patients with de quervain's tenosynovitis and symptoms of depression. the toolkit is delivered online and can be accessed at home. similar skills interventions in patients with musculoskeletal injury have been shown to improve pain and function.

Eligibility criteria:
inclusion criteria: * adults (≥18 years) diagnosed with de quervain's tenosynovitis * english fluency and literacy * ability to give informed consent exclusion criteria: * inability or unwillingness to participate in decision aid (da) and/or toolkit-depression * major medical comorbidity expected to worsen in the next 6 months * comorbid chronic pain condition * antidepressant medications changes in the past 6 months * severe and untreated mental health conditions or active substance dependence * secondary gains such as litigations or worker compensation procedures that may interfere with patients' motivation for treatment * no online device available to use the da and toolkit-depression
proof-of-concept clinical pharmacology trial for covid-19 antigen presentation therapeutic biologic mix

Conditions: Covid19

Summary: conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of covid-19 patients with controlled cancers. 1. treat infection of multiple gene mutation covid-19 virus strains. 2. activate human antigen presentation reaction to covid-19 specific antigen. 3. the human antigen presenting cells (apcs) can take up and process covid-19 target antigen protein into small peptide fragments, and then covid-19 virus can be killed by apcs directly.

* conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of covid-19 patients with controlled cancers. * 20 moderate covid-19 patients with controlled cancers * moderate covid-19 * positive testing by standard rt-pcr assay or equivalent testing * symptoms of moderate illness with covid-19, which could include any symptom of mild illness or shortness of breath with exertion * clinical signs suggestive of moderate illness with covid-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (spo2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute * no clinical signs indicative of severe or critical illness severity * novavax covid-19 vaccine 1.0 ml plus bcg organism 50 mg mix * by the percutaneous route with the multiple puncture device * negative testing covid-19 by standard rt-pcr assay or equivalent testing after injection 3 weeks. * positive igra blood test with covid-19 spike protein antigen after percutaneous use 21 days. * our trial duration will be 4 weeks.

Eligibility criteria:
* conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of covid-19 patients with controlled cancers. * 20 moderate covid-19 patients with controlled cancers inclusion criteria: * controlled cancers * moderate covid-19 * positive testing by standard rt-pcr assay or equivalent testing * symptoms of moderate illness with covid-19, which could include any symptom of mild illness or shortness of breath with exertion * clinical signs suggestive of moderate illness with covid-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (spo2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute * no clinical signs indicative of severe or critical illness severity exclusion criteria: * 1. uncontrolled cancers * 2. severe or critical illness severity * 3. pregnancy * 4. breast-feeding * 5. the patients with other serious inter-current illness * 6. serious allergy * 7. serious bleed tendency * 8. the prohibition of the biological product

Keywords: gene mutation antigen presentation apc spike covid-19
adherence to exercises for neck pain.

Conditions: Treatment Adherence and Compliance

Summary: this project continuing to study on the effectiveness of a chatbot in promoting adherence to home physiotherapy treatment for patients, in this case, with cervical musculoskeletal injuries and pain. the use of digital technologies and media is an important option to complement in-person treatment and promote adherence to treatment at home. the research aims to verify whether the use of a chatbot as a means of communication can produce improvements in patient adherence and clinical results.


Eligibility criteria:
inclusion criteria: * over 18 years. * diagnosis of cervical pain. * indication of treatment through home exercises. * with a personal smartphone * verbally confirms to have installed an instant messaging service or app, and accesses it at least 3 times a week exclusion criteria: * no to sign the informed consent. * not able to understand, read and write in the spanish language

Keywords: treatment adherence new technologies back pain
pulmonary rehabilitation in asthma control

Conditions: Asthma

Summary: the investigators compared the effectiveness of pulmonary rehabilitation program on asthma control in patients with uncontrolled and partially controlled asthma.

asthma treatment is not only medical, it also requires a comprehensive care including nonpharmacological treatment. pulmonary rehabilitation represents the most important part of the comprehensive care. the investigators aimed to evaluate the efficacy of pulmonary rehabilitation in patients with uncontrolled and partially controlled asthma. asthma patients referred to pulmonary rehabilitation (pr) unit were classified according to asthma control test; as partially controlled patients (group 1), and as uncontrolled patients (group 2). all patients received of a 8 week pulmonary rehabilitation program. asthma control tests, pulmonary function tests, arterial blood gases analysis, dyspnea perception, quality of life, exercise capacity, anxiety and depression assessments were performed before and after pulmonary rehabilitation.

Eligibility criteria:
inclusion criteria: * asthmatic patients referred from the outpatient clinic to pulmonary rehabilitation unit was confirmed according to gina guidelines exclusion criteria: * if the initial diagnosis cannot be confirmed, the patient excluded from the study * patients were under medical treatment of -6 months and considered clinically stable. * patients with cardiovascular, other lung diseases (pneumoconiosis, pulmonary tuberculosis, interstitial lung disease), or musculoskeletal diseases that would impair exercise training were excluded from the study. * also subjects with lack of motivation, poor compliance (not attending the program more than 2 times) or having transport problems were excluded from the study

Keywords: asthma control pulmonary rehabilitation
early extracorporeal shockwave therapy for erectile dysfunction in radically prostatectomised men.

Conditions: Erectile Dysfunction; Extracorporeal Shockwave Therapy; Radical Prostatectomy

Summary: the purpose of this project is to assess the relationship between low intensity shock wave treatment (li-swt) and erectile function (ed) in patients who have undergone radical prostatectomy (rp).


Eligibility criteria:
inclusion criteria: * radically prostatectomised men * non nerve-sparing or nerve-sparing rp. * age 20-80 years * have been in a relationship for more than 3 months. * sexually active * patient can give informed consent. exclusion criteria: * men with ed of neuropathological or psychogenic origin * rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded. * patients with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.

Keywords: radical prostatectomy prostatectomy nerve-sparing non nerve-sparing erectile dysfunction erectile function shockwave li-eswt eswt low intensity extracorporeal shockwave therapy extracorporeal shockwave therapy
advate 2 ml post-authorization safety surveillance (pass)

Conditions: Hemophilia A; Congenital Factor VIII (FVIII) Deficiency

Summary: this is a post-authorization safety surveillance (pass) study designed to collect data on the safety and effectiveness of advate reconstituted in 2 ml sterile water for injection (swfi) during routine clinical practice in children until 12 years of age. this surveillance study is a post-licensure commitment for advate reconstituted in 2 ml swfi.


Eligibility criteria:
inclusion criteria: * severe or moderately severe hemophilia a (baseline factor viii (fviii) ≤ 2%) * ≤12 years of age * participant's legally authorized representative(s) has provided written informed consent * participant is prescribed advate and will only receive advate reconstituted in 2 ml sterile water for injection (swfi) * documented history of prior exposure to advate * documented evidence of negative inhibitor test result during ≤10 eds prior to study entry exclusion criteria: * known hypersensitivity to the active substance or to any of the excipients * known allergic reaction to mouse or hamster proteins * participant has a requirement for a major surgical procedure at the time of enrollment * participant has no prior exposure to a fviii concentrate * participant currently being treated with an immune tolerance induction (iti) regimen * participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia a (eg, qualitative platelet defect or von willebrand disease) * participant has participated in another clinical study involving an investigational product (ip) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an ip or investigational device or pass registry during the course of this study
effect of cholecalciferol supplementation on disease activity and quality of life of systemic lupus erythematosus patients .

Conditions: Lupus Erythematosus, Systemic; Cholecalciferol Supplementation; Disease Activity; Quality of Life

Summary: increase in the prevalence and survival rates has led to the assessment of disease activity and quality of life of sle patients as targets in treatment. cholecalciferol supplementation was considered as having a role in reducing disease activity and improving quality of life.this research was a double blind, randomized, controlled trial was conducted on female outpatients aged 18-60 years with sle, consecutively recruited from september to december 2021 at cipto mangunkusumo hospital. sixty subjects who met the research criteria were randomized and equally assigned into the cholecalciferol and placebo groups. the study outcomes were measured at baseline and after 12 weeks of intervention. we measured he level of vitamin d before and after intervention, the disease activity by mex-sledai score and the quality of life by lupus qol


Eligibility criteria:
inclusion criteria: * women subjects aged 18-60 years old with hypovitaminosis d exclusion criteria: * declining consent to participate, late stage chronic kidney disease (staged 4-5), decompensated liver cirrhosis, consumption of glucocorticoids (equivalent to prednisone 20 mg/day) in the past 30 days, pregnant or lactating, patients with acute infection, hypercalcemic patients, anticonvulsant consumption.

Keywords: lupus erythematosus systemic cholecalciferol supplementation mex-sledai score lupus qol